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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
P1.01-071 - Long-Term Tolerability Among IRESSA Clinical Access Program (ICAP) Participants in the United States (US) (ID 780)
09:30 - 17:00 | Author(s): E.F. Croft
Following the gefitinib (IRESSA[®]) NDA voluntary withdrawal, which previously had allowed for limited commercial distribution of IRESSA, gefitinib became available under the IRESSA Clinical Access Program (ICAP) in June 2011. The ICAP continued to provide drug access to patients who were benefiting or had benefited from treatment with gefitinib through restricted distribution (2005-2011) or through a clinical trial that was IRB approved prior to June 2005. ICAP participants constitute a unique subset of cancer patients in whom long-term use of gefitinib can be studied. Consequently, this is the first study to describe long-term safety and tolerability data for an EGFR TKI in cancer patients outside of the clinical trial setting.
This study utilizes 2 data sources: (1) retrospective patient medical chart review of demographics, including safety and tolerability of prolonged treatment with gefitinib as part of the ICAP; and (2) retrospective review of serious adverse event (SAE) reports in the AstraZeneca safety database, as all ICAP investigators are responsible, per protocol, for reporting all SAEs observed for ICAP participants.
A total of 188 patients were enrolled in the ICAP from 134 sites across the US; 94 patients (50.0%) remain on active treatment. This study aims to include as many sites and patients as feasible. Currently, 46 sites representing 77 patients have agreed to participate; site enrollment and data collection are ongoing. As of July 16, 2015, chart abstractions of 16 patients were completed. These patients have a median age of 68.0 years, are predominantly female (75.0%), non-Hispanic white (87.5%), with a confirmed NSCLC diagnosis (93.8%). More patients received gefitinib in second line (43.8%) followed by first line (37.5%) and third line (18.8%). Median gefitinib duration prior to ICAP initiation was 11.3 years (range 9.1-13.9 years), with median gefitinib duration as part of the ICAP being an additional 3.5 years (range: 0.3-3.8 years). During the ICAP, 93.8% of patients (95% CI: 87.9-99.6) did not experience any dose reductions, interruptions, or discontinuation due to gefitinib-related adverse events. The AstraZeneca Safety Database showed 123 SAEs reported from 54 ICAP patients as of February 26, 2015. The majority of SAEs were consistent with underlying disease conditions and were considered unrelated to gefitinib therapy by investigators. 5.6% of patients (3/54) had potentially causally related SAEs as determined by investigators: one patient had procedure-related bronchitis, lung infection, and exacerbation of preexisting COPD with a fatal outcome; one patient experienced interstitial lung disease, pulmonary alveolar hemorrhage, and acute respiratory and renal failure (patient recovered with sequelae); and one patient developed dermatitis acneiform and pruritus. Of the remaining 51 patients, 20 had fatal outcomes (39.2%). The majority of fatalities (12) had insufficient information to assess cause of death and may have had other alternative causes, including underlying or concurrent diseases (6) and possible disease progression (2).
: Characterization of long-term gefitinib use among this subset of NSCLC patients indicates acceptable long-term tolerability and indicates that some patients have long-term (>10 year) benefit. Clinical and genetic features associated with long-term benefit need further study.
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